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RecruitingNCT07626151Updated Jun 8, 2026

Electric Cardiometry-Guided Standard Versus Restricted Fluid Therapy In Robotic Prostaectomy

An interventional study of Liberal Fluid Therapy and Restricted Fluid Therapy in Prostate Cancer, Surgery and Fluid Overload, sponsored by Nazmy Edward Seif. Recruiting at 1 site in Egypt. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Nazmy Edward Seif · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
Male
01

Study summary

Fluid therapy during surgery is an important factor that is related to long term mortality and morbidity and it's directly related to tissue perfusion as well. The main target in any surgery is what is the optimum fluid therapy to maintain the tissue perfusion and the precise balance between hazardous effects of hypervolemia that may cause delayed wound healing due to surgical anastomosis disruption or being hypovolemic that may cause tissue ischemia as acute kidney injury.

Fluid management guidance changed from static methods like central venous pressure into dynamic methods like pulse pressure variation (PPV) and stroke volume variation (SVV), which are now the most famous dynamic measures.

Electrical cardiometry is a non-invasive cardiac output monitor which uses electrical cardiometry, now a commonly used device, to measure SVV which can be used to guide fluid therapy during surgeries.

Now robotic assisted surgery is a common method in preforming many surgeries especially urological, since it's associated with numerous desirable outcomes including shorter post-operative stay and faster return to preoperative function.

With considerations related to severe Trendelenburg position and increased intra-abdominal pressure due to pneumo-peritoneum, robotic assisted surgeries are associated with many challenges in anesthesia especially the fluid therapy.

Fluid therapy in robotic surgeries is an area with growing research focus that need further exploration while there are established guidelines for fluid management in traditional surgeries, the optimal protocols for robotic surgeries are less well defined, needing more research.

We aim at this study to investigate the impact of liberal versus restricted fluid intake on the tissue perfusion reflected by serum lactate \& creatinine clearance, while guiding therapy through electrical cardiometry, to reach optimum fluid protocol in prostatic robotic surgeries.

02

Conditions studied

  • Prostate Cancer
  • Surgery
  • Fluid Overload
  • Lactate Blood Increase

Keywords

  • Robotic
  • Prostatectomy
  • Sugery
  • Anesthesia
  • Fluid
  • Electric Cardiometry
  • Tissue Perfusion
03

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Male patient undergoing robotic assisted prostatectomy
  • ASA I-III

Exclusion criteria

Exclusion Criteria:

  • ASA score more than III
  • BMI more than 40
  • Severe renal disease (GFR between 15 and 29)
  • Previous renal surgery.
  • Decompensated cardiac disease (NYHA class 3 or 4)
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Liberal Group

    Liberal Fluid Therapy Group

    Procedure: Liberal Fluid Therapy

  • Active comparator
    Restricted Group

    Restricted Fluid Therapy Group

    Procedure: Restricted Fluid Therapy

Interventions

  • ProcedureLiberal Fluid Therapy

    Patients will receive 6 ml/kg/hour of lactated ringer for maintenance in addition to fasting hours compensation (2 ml/kg for each fasting hour, given as 50% in the first hour of surgery, then 25% during the second \& third hours). An additional bolus of 200 ml Lactated Ringer will be given if MAP is below 65 mmHg. In case of persistent hypotension despite proper fluid rescuistation, 10 mg of Ephedrine will be administered; if no response is achieved, norepinerhine infusion will start at initial dose 0.01mcg/kg/min if MAP is below 65 mmHg.

  • ProcedureRestricted Fluid Therapy

    Patients will receive 2 ml/kg as fluid bolus then 2 ml/kg/hour for maintenance, aiming at a target SVV less than 13 %. Patients with SVV ≥ 13% will be considered fluid responder and will receive a fluid bolus of 200 ml Ringer Lactated Ringer over 10 minutes.The fluid bolus will be repeated until the SVV is less than 13%. In case of persistent hypotension (MAP less than 65mmHg), 10 mg of Ephedrine will be administered; if no response is achieved, norepinerhine infusion will be started at intial dose 0.01mcg/kg/min if MAP is below 65 mmHg.

05

What researchers measure

Primary outcomes

  1. Serum Lactate level difference

    Serum Lactate level difference between pre-operative (baseline) value and post-operative (recovery) value in mmol/L

    Time frame: 24 hours

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT07626151
Lead sponsor
Nazmy Edward Seif
Responsible party
Nazmy Edward Seif (Clinical Professor, Cairo University) — Sponsor-investigator
First posted
Jun 4, 2026
Start date
Jun 5, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 8, 2026

Study contacts

Mohamed M Mohamed, M.Sc.
Contact
mandamembo0@gmail.com
+20 111 8370641
Nazmy S Mikhael, M.D.
Contact
drnazmyseif@kasralainy.edu.eg
+20122 7400808
Ashgan R Aly, M.D.
study chair · Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Nazmy S Mikhael, M.D.
principal investigator · Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Mohamed M Mohamed, M.Sc.
study director · Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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